UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020304
Receipt number R000023428
Scientific Title Multicentric survey of acute on chronic liver failure in Japan
Date of disclosure of the study information 2015/12/22
Last modified on 2018/06/24 11:51:00

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Basic information

Public title

Multicentric survey of acute on chronic liver failure in Japan

Acronym

Multicentric survey of ACLF in Japan

Scientific Title

Multicentric survey of acute on chronic liver failure in Japan

Scientific Title:Acronym

Multicentric survey of ACLF in Japan

Region

Japan


Condition

Condition

Acute on chronic liver failure

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Emergency medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the outocme of patients with ACLF seen between 2011 and 2014 retrospectively.

Basic objectives2

Others

Basic objectives -Others

Trend

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

APASL definition of ACLF

Key secondary outcomes

EASL-CLIF consortium definition of ACLF
Diagnostic criteria of Chinese Medical Association (CMA)


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

APASL criteria
CMA criteria
EASL-CLIF Consortium criteria

Key exclusion criteria

APASL criteria
CMA criteria
EASL-CLIF Consortium criteria

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoshi Mochida

Organization

Saitama Medical University

Division name

Department of Gastroenterology & Hepatology

Zip code


Address

Morohongo 38, Moroyama-Machi, Saitama, Japan

TEL

049-2761198

Email

alfsg@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nobuaki Nakayama

Organization

Saitama Medical University

Division name

Department of Gastroenterology & Hepatology

Zip code


Address

Morohongo 38, Moroyama-Machi, Saitama, Japan

TEL

049-276-1198

Homepage URL


Email

alfsg@saitama-med.ac.jp


Sponsor or person

Institute

Health Labour Sciences Research Grant, Research on Measures for Intractable Diseases from the Ministry of Health, Labor and Welfare of Japan

Institute

Department

Personal name



Funding Source

Organization

Health Labour Sciences Research Grant, Research on Measures for Intractable Diseases from the Ministry of Health, Labor and Welfare of Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 22 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2014 Year 10 Month 23 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We conducte a pilot study on ACLF in Japan.


Management information

Registered date

2015 Year 12 Month 22 Day

Last modified on

2018 Year 06 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023428


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name